NRG-LU001
Terminated
Protocol Information
Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC
Principal Investigator
Theos Tsakiridis
Status
Terminated
Open to Accrual
August 4, 2014
Open to Accrual
August 25, 2014
Closed to Accrual
December 15, 2016
Closed to Accrual & Treatment
April 14, 2017
Complete
September 4, 2025
Terminated
September 4, 2025
Disease Site
Lung [LU] Non-small Cell Lung Cancer
Phase
II
Developmental Therapeutics
No
Primary Objective
To determine whether MET added to chemoradiotherapy can improve progression-free survival (PFS) in patients with locally advanced NSCLC
Patient Population
Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer; patients must have unresectable disease, are medically inoperable, or are not willing to undergo surgical management.
Target Accrual
168
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
- NRG-LU001-Study-Memorandum-Amendment-1-June-15-2015.pdf
- NRG-LU001-Study-Memorandum-Amendment-2-September-6-2016.pdf
- NRG-LU001-Study-Memorandum-Amendment-3-December-26-2018.pdf
- NRG-LU001-Study-Memorandum-Closure-December-15-2016.pdf
- NRG-LU001-Study-Memorandum-Closure-Notice_December-13-2016.pdf
- NRG-LU001-Study-Memorandum-November-3-2014.pdf
- NRG-LU001_Study-Memorandum-September-10-2015.pdf
- 0279-Amendment-2-tracked.pdf
Patient Study Webpage
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